Hydromorphone and C-section

Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief

This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy women undergoing cesarean section

Exclusion Criteria:

• Any comorbidities other than obesity, hypertension, fetal anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydromorphone; Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally	Drug: Hydromorphone; Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	12 hours after intrathecal injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	Baseline
Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	6 hours after intrathecal injection
Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	18 hours after intrathecal injection
Pain Scores, Visual Analogue Pain Scale	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).	24 hours after intrathecal injection

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Grant C Lynde, MD, Emory University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: IRB00058097